Free From Maintenance Drug Therapy in Multiple Myeloma (The FREEDMM Trial) for Minimal Residual Disease (MRD

Summary

A pilot study to assess the risk of progression after stopping post-autologous stem cell transplant (ASCT) maintenance therapy in Minimal Residual Disease (MRD)-negative MM patients.

Eligibility

Inclusion Criteria:

* ECOG Performance Status equal to or less than 2 within 30 days prior to registration
* Revised International Staging System (R-ISS) I,2 or 3
* Patients with multiple myeloma as defined by IMWG
* Received at least 2 years of post ASCT maintenance (patients may have received any number of prior lines of therapy).
* Maintenance therapy is defined as any anti-myeloma therapy initiated after ASCT to prevent disease recurrence and prolong time in remission (i.e., lenalidomide, bortezomib, RVD, etc.)
* Disease response is VGPR or CR at the time of enrollment as defined by IMWG criteria.
* Patients or their legally authorized representative must be able to understand and be willing to sign a voluntary informed consent form and agree to compliance with the protocol schedule; with the knowledge that they may withdraw consent at any time without impact on future medical care

Exclusion Criteria:

* Patients with plasma cell leukemia, AL amyloidosis or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin (POEMS) syndrome
* Prior organ transplant or condition requiring immunosuppressive therapy
* Prior allogeneic hematopoietic cell transplant
* Treatment with any investigational drug within 30 days prior to enrollment
* Unable to sign an informed consent or their legally authorized represnetative

Conditions2

Locations1 site

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